510(k) K171893

Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate) by Bluestone Synergy — Product Code MAX

K171893 is an FDA 510(k) premarket notification submitted by Bluestone Synergy for the device "Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate)". The FDA issued a decision of Substantially Equivalent on Sep 8, 2017. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080.